Ciclosporin in the management of ENL reactions

Lambert, S. 2015. Ciclosporin in the management of ENL reactions. [Online]. London School of Hygiene & Tropical Medicine, London, United Kingdom. Available from: https://doi.org/10.17037/DATA.17.

Lambert, S. Ciclosporin in the management of ENL reactions [Internet]. London School of Hygiene & Tropical Medicine; 2015. Available from: https://doi.org/10.17037/DATA.17.

Lambert, S (2015). Ciclosporin in the management of ENL reactions. [Data Collection]. London School of Hygiene & Tropical Medicine, London, United Kingdom. https://doi.org/10.17037/DATA.17.

Description

Data produced as part of a clinical trial to compare the efficacy and safety of Ciclosporin and Prednisolone in the Treatment of Erythema Nodosum Leprosum (ENL). The trial was conducted with two randomised, double blind, controlled groups in Ethiopia. The first group had acute first time occurrence of ENL and the second group had recurrent ENL. Both groups were randomized to one of two study arms: the ciclosporin treatment arm or the prednisolone treatment arm. Patients were followed over a 32 week period, where they were assessed for changes in clinical signs and adverse events.

Methods

Description of data capture

Data from each assessment was recorded on standardised Patient Record Forms (PRF) and kept in a set of case notes separate from other hospital record. Data was verified and entered into Case Record Forms (CRF) by the study physicians. Double data entry into a Microsoft Access 2007 database was performed by Saba Lambera and a data manager at ALERT/AHRI. Double entry was then verified using Epi-Info 3.5.4. The initial rate of errors detected by double entry was just under 10%. Errors in the data were verified and corrected in Ethiopia. Errors were traced back to the CRFs and correct. Epi-info was re-run and procedures repeated until two identical and correct databases were obtained. Finally, the MS Access data tables were transferred to SPSS v20 for analysis.

Data capture method

Measurements and tests

Data Collection Period

From	To
12 August 2011	10 May 2012

Date (Date submitted to LSHTM repository)

1 October 2015

Geographical area covered (offline during plugin upgrade)

North Latitude	East Longitude	South Latitude	West Longitude
9.06403	38.8541	8.90533	38.6321

Language(s) of written materials

English

People & Groups

Data Creators	Lambert, S
Associated roles	Nicholls, P (Data Manager), Yamuah, L, Lockwood, D, Tsegaye, D (Project Leader) and Nigusse, S
LSHTM Faculty/Department	Faculty of Public Health and Policy > Dept of Public Health, Environments and Society
Participating Institutions	London School of Hygiene & Tropical Medicine, London, United Kingdom

Projects

Funders

Project	Funder	Grant Number	Funder URI
Assessing Ciclosporin in the Treatment of Leprosy Reactions: Evidence from a Randomized Controlled Trial and Other Studies	Hospital and Homes of St Giles	ITCRBY24	UNSPECIFIED